The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration
NCT ID: NCT00857259
Last Updated: 2011-08-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Everolimus 5 mg
5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
Everolimus
5 mg oral tablet
Ranibizumab 0.5 mg
Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
Ranibizumab
0.5 mg administered by intravitreal injection
Oral Everolimus (5mg) and Ranibizumab (0.5mg)
Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
Everolimus
5 mg oral tablet
Ranibizumab
0.5 mg administered by intravitreal injection
Interventions
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Everolimus
5 mg oral tablet
Ranibizumab
0.5 mg administered by intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity ( BCVA) of 20/40 or worse in study eye
* Patients with predominantly classic, minimally classic, or occult choroidal neovascularization in the macula of one eye (the study eye) who have had an inadequate response to VEGF inhibitors in the study eye. Inadequate response is defined as a gain of less than one line of visual acuity and persistent macular edema (central sub-fiel thickness ≥ 300 μm as measured by Optical Coherence Tomography (OCT) despite a minimum of 3 treatments with Lucentis or Avastin
Exclusion Criteria
* Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke
* Patients who have macular edema in the study eye that, in the judgment of the investigator, is unlikely to respond to treatment. Examples of features that may guide the investigator's judgment about unresponsiveness are large regions of geographic atrophy, retinal angiomatous proliferation, or large regions of sub-retinal fibrosis. The presence of one of these features excludes a patient only if the investigator judges the study eye to have irreversible macular edema.
* active bacterial, fungal or viral infections at the time of enrollment, e.g. hepatitis B or C infection. Patients with risk factors for hepatitis B should be tested for hepatitis B viral load and serological markers at screening (a positive HBV-DNA, HBsAg). Patients with risk factors for hepatitis C should be tested using HCVRNA-PCR at screening. A clinical history of hepatitis B or hepatitis C will exclude the patient from the study.
50 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Porter Adventist Hospital, Diagnostic Eye Laboratory
Denver, Colorado, United States
Discover Vision Center
Independence, Missouri, United States
Novartis Investigative Site
Bristol, , United Kingdom
Novartis Investigative Site
Frimley, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Oxford, , United Kingdom
Novartis Investigative site
Portsmouth, , United Kingdom
Novartis Investigative Site
Southampton, , United Kingdom
Novartis Investigator Site
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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EudraCT number: 2008-003550-15
Identifier Type: -
Identifier Source: secondary_id
CRAD001A2203
Identifier Type: -
Identifier Source: org_study_id
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